The Role of Smoking in Periodontal Status (TRSPS)

December 8, 2025 updated by: Tuğba ŞAHİN

The Role of Smoking Habits in Periodontal Health and Disease: A Cross-Sectional Study

484 patients were asked whether they currently smoked and whether they had smoked 100 or more cigarettes during their lifetime. Based on this information, they were divided into two groups: current smokers (test group, n=242) and non-smokers (control group, n=242). Current smokers were defined as individuals who had smoked ≥100 cigarettes in their lifetime and continued smoking. In contrast, non-smokers included individuals who had smoked fewer than 100 cigarettes in their lifetime and were not currently smoking. Participants were also asked about the number of cigarettes smoked per day and the duration of smoking in years, and pack-years were calculated accordingly. Plaque index, gingival index, probing depth, bleeding on probing, gingival recession, and attachment loss were evaluated for both groups. Periodontal health status (Periodontal health, gingivitis, and periodontitis) was assessed by one clinician applying the 2017 World Workshop on Classifying Periodontal and Peri-Implant Diseases and Conditions and the 2023 European Federation of Periodontology's Guidelines. Patients with periodontitis were classified according to stage and grade. This measurement was obtained via a calibrated UNC-15 periodontal probe at each tooth.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

484 patients were asked whether they currently smoked and had smoked 100 or more cigarettes during their lifetime. Based on this information, they were divided into two groups: current smokers (test group, n=242) and non-smokers (control group, n=242). Current smokers were defined as individuals who had smoked ≥100 cigarettes in their lifetime and continued smoking. In contrast, non-smokers included individuals who had smoked fewer than 100 cigarettes in their lifetime and were not currently smoking. Participants were also asked about the number of cigarettes smoked per day and the duration of smoking in years, and pack-years were calculated accordingly. Plaque index, gingival index, probing depth, bleeding on probing, gingival recession, and attachment loss were evaluated for both groups. Periodontal health status (Periodontal health, gingivitis, and periodontitis) was assessed by one clinician applying the 2017 World Workshop on Classifying Periodontal and Peri-Implant Diseases and Conditions and the 2023 European Federation of Periodontology's Guidelines. Patients with periodontitis were classified according to stage and grade. This measurement was obtained via a calibrated UNC-15 periodontal probe at each tooth.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
484

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Bolu, Turkey (Türkiye), 14030
        • Bolu Abant Izzet Baysal University, Dentistry Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study includes patients who are smokers and those who are non-smokers.

Description

Inclusion Criteria:

  • Age 18 years or older
  • No systemic diseases that could affect periodontal or general health
  • No history of periodontal treatment within the past six months
  • For the non-smoker group: abstinence from smoking for at least five years

Exclusion Criteria:

  • Use of antibiotics or anti-inflammatory drugs
  • Pregnant or lactating women
  • Diabetes mellitus
  • Use of waterpipe or chewing tobacco (for the smoker group)
  • Individuals undergoing chemotherapy or radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Smoker
Current smokers were defined as individuals who had smoked ≥100 cigarettes in their lifetime and continued smoking.
Other: Intervention
The patient's daily cigarette consumption, duration of smoking, and pack-years were evaluated.
Other Names:
  • Smoking
Non-smoker
Non-smokers included individuals who had smoked fewer than 100 cigarettes in their lifetime and were not currently smoking.
Other: Intervention
The patient's daily cigarette consumption, duration of smoking, and pack-years were evaluated.
Other Names:
  • Smoking

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
periodontal pocket depth
Time Frame: Baseline
Periodontal pocket depth measured in millimeters using a Williams periodontal probe. The distance from the gingival margin to the bottom of the periodontal pocket was recorded at each site.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
bleeding on probing
Time Frame: Baseline
Bleeding on probing assessed using a periodontal probe. After gently inserting the probe into the gingival sulcus and moving it laterally along the pocket wall, bleeding was recorded as present (+) or absent (-).pocket and gently moved laterally along the pocket wall. + is maximum and - is minimum.
Baseline
plaque index
Time Frame: Baseline
Oral hygiene status assessed using the Plaque Index, which measures dental plaque accumulation adjacent to the gingival margin. Scores range from 0 (no plaque) to 3 (abundant plaque), with higher scores indicating poorer oral hygiene.
Baseline
gingival index
Time Frame: Baseline
Gingival inflammation assessed using the Löe and Silness Gingival Index. Each site was scored on a 0-3 scale, where 0 = normal gingiva and 3 = severe inflammation with edema, redness, and spontaneous bleeding. Higher scores indicate worsening gingival inflammation.
Baseline
clinical attachment level
Time Frame: Baseline
Clinical attachment level measured in millimeters using a periodontal probe. CAL was calculated as the distance from the cementoenamel junction to the bottom of the periodontal pocket and used to assess periodontal tissue support loss.
Baseline
Daily cigarette
Time Frame: Baseline
It includes the number of cigarettes smoked per day. Self-reported number of cigarettes smoked per day.
Baseline
Smoking Duration
Time Frame: Baseline
Self-reported duration of smoking, recorded as the number of years the participant has smoked.
Baseline
Pack-years
Time Frame: Baseline
Smoking exposure calculated as pack-years, defined as the number of cigarettes smoked per day divided by 20 and multiplied by the number of years of smoking.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tuğba ŞAHİN

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: TUGBA SAHIN, Abant Izzet Baysal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 2, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BAIBU-DH-TS-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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